– Phase 1b/2 clinical trial expected to
begin enrolling patients before year-end 2023 –
Exelixis, Inc. (Nasdaq: EXEL) and Arcus Biosciences (NYSE: RCUS)
today announced that the companies have entered into a clinical
trial collaboration for STELLAR-009, a phase 1b/2 trial evaluating
zanzalintinib, Exelixis’ next-generation tyrosine kinase inhibitor
(TKI), in combination with AB521, an inhibitor of the transcription
factor HIF-2⍺, in patients with advanced solid tumors, including
clear cell renal cell carcinoma (ccRCC). Exelixis is sponsoring
STELLAR-009, and Arcus is co-funding the study and providing AB521
for use in the trial. Patient enrollment for STELLAR-009 is
expected to begin before the end of 2023.
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“We are excited to learn more about the potential effects of
zanzalintinib plus Arcus’ HIF-2⍺ inhibitor, as these two molecules
approach the inhibition of cancer cell proliferation and tumor
angiogenesis from differing angles, and combination therapy may
provide better outcomes than either therapy alone,” said Amy
Peterson, M.D., Executive Vice President, Product Development &
Medical Affairs, and Chief Medical Officer, Exelixis. “We have a
long-established commitment to advancing treatment options in
kidney cancer, and we are eager to maximize the potential of
zanzalintinib through this collaboration with Arcus and look
forward to advancing the combination in the clinic.”
“We are excited to partner with Exelixis on the STELLAR-009
study to determine the best-in-class potential of AB521 in
combination with zanzalintinib and look forward to generating a
robust set of data to move this combination into full development,”
said Dimitry S.A. Nuyten, M.D., Ph.D., Chief Medical Officer of
Arcus Biosciences. “The STELLAR-009 study is an important step in
the development of AB521 and enables a cost-effective path to
evaluating our HIF-2⍺ inhibitor with a next-generation TKI.”
The dose-finding stage of this open-label study will determine a
recommended dose for zanzalintinib in combination with AB521 in
patients with advanced solid tumors and in patients with advanced
ccRCC. Expansion cohorts will further evaluate the tolerability and
activity of this combination in ccRCC as well as investigate the
contribution of components, supported by activity data generated
from monotherapy studies in ccRCC patients, to support full
development.
More information about this trial will be available soon on
ClinicalTrials.gov.
About Zanzalintinib Zanzalintinib is a next-generation
oral TKI that inhibits the activity of receptor tyrosine kinases
implicated in cancer growth and spread, including VEGF receptors,
MET, AXL and MER. These receptor tyrosine kinases are involved in
both normal cellular function and in pathologic processes such as
oncogenesis, metastasis, tumor angiogenesis and resistance to
multiple therapies, including immune checkpoint inhibitors (ICIs).
With zanzalintinib, Exelixis sought to build upon its extensive
experience with the target profile of cabozantinib, the company’s
flagship medicine, while improving key characteristics, including
pharmacokinetic half-life. Zanzalintinib is currently being
developed for the treatment of advanced solid tumors, including
genitourinary, colorectal and head and neck cancers.
About AB521 AB521 is a small molecule inhibitor of
HIF-2⍺, a transcription factor involved in oxygen sensing in
multiple organs as well as in tumors. Clear cell RCC is almost
universally associated with HIF-2⍺ dysregulation as a result of
genetic abnormalities in the VHL pathway. This creates a situation
of pseudohypoxia and the abnormal increase in HIF-2⍺-mediated
expression of a wide array of proteins involved in cancer cell
proliferation and survival, treatment resistance and angiogenesis.
Arcus is currently evaluating AB521 in ARC-20, a phase 1/1b study
in cancer patients. Enrollment for the dose-expansion stage in
ccRCC patients is complete for the target dose of 100 mg, and
efficacy data from this stage are expected in 2024. In the
dose-escalation stage up to 100 mg, as of December 1, 2023,
pharmacokinetic and pharmacodynamic data were consistent with the
data generated in healthy volunteers, and no dose-limiting
toxicities were observed. AB521 has the potential to achieve
substantially greater HIF-2⍺ inhibition than the approved dose of
the marketed competitor.
About RCC Kidney cancer is among the top ten most
commonly diagnosed forms of cancer among both men and women in the
U.S.1 An estimated 81,800 Americans will be diagnosed with kidney
cancer in 2023.1 Clear cell RCC is the most common type of kidney
cancer in adults.2 If detected in its early stages, the five-year
survival rate for RCC is high; for patients with advanced or
late-stage metastatic RCC, however, the five-year survival rate is
only 15%.3 In 2022, approximately 32,200 patients with advanced
kidney cancer required systemic therapy in the U.S., with over
20,000 patients receiving first-line treatment.4
About Exelixis Exelixis is a globally ambitious
oncology company innovating next-generation medicines and regimens
at the forefront of cancer care. Powered by bi-coastal centers of
discovery and development excellence, we are rapidly evolving our
product portfolio to target an expanding range of tumor types and
indications with our clinically differentiated pipeline of small
molecules, antibody-drug conjugates and other biotherapeutics. This
comprehensive approach harnesses decades of robust investment in
our science and partnerships to advance our investigational
programs and extend the impact of our flagship commercial product,
CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific
pursuit to create transformational treatments that give more
patients hope for the future. For information about the company and
its mission to help cancer patients recover stronger and live
longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter),
like Exelixis, Inc. on Facebook and follow Exelixis on
LinkedIn.
About Arcus Biosciences Arcus Biosciences is a
clinical-stage, global biopharmaceutical company developing
differentiated molecules and combination medicines for people with
cancer. In partnership with industry partners, patients and
physicians around the world, Arcus is expediting the development of
first- or best-in-class medicines against well-characterized
biological targets and pathways and studying novel, biology-driven
combinations that have the potential to help people with cancer
live longer. Founded in 2015, the company has expedited the
development of multiple investigational medicines into clinical
studies, including new combination approaches that target TIGIT,
PD-1, the adenosine axis (CD73 and dual A2a/A2b receptor), HIF-2a,
CD39 and AXL. For more information about Arcus Biosciences’
clinical and preclinical programs, please visit www.arcusbio.com or
follow us on X.
Exelixis Forward-Looking Statements This press release
contains forward-looking statements, including, without limitation,
statements related to: the therapeutic potential of zanzalintinib
in combination with AB521 to improve outcomes for patients with
advanced solid tumors, including ccRCC, and for the combination to
provide better outcomes than either therapy alone; Exelixis’
expectation that patient enrollment for STELLAR-009 will begin
before the end of 2023; Exelixis’ plans to continue studying the
therapeutic potential of zanzalintinib in kidney cancer, as well as
in other advanced solid tumors; and Exelixis’ scientific pursuit to
create transformational treatments that give more patients hope for
the future. Any statements that refer to expectations, projections
or other characterizations of future events or circumstances are
forward-looking statements and are based upon Exelixis’ current
plans, assumptions, beliefs, expectations, estimates and
projections. Forward-looking statements involve risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in the forward-looking statements
as a result of these risks and uncertainties, which include,
without limitation: complexities and the unpredictability of the
regulatory review and approval processes in the U.S. and elsewhere;
Exelixis’ and Arcus Biosciences’ continuing compliance with
applicable legal and regulatory requirements; the potential failure
of zanzalintinib in combination with AB521 to demonstrate safety
and/or efficacy in STELLAR-009 and in future clinical testing;
uncertainties inherent in the product development process,
including evolving regulatory requirements, slower than anticipated
patient enrollment or inability to identify a sufficient number of
clinical trial sites; the costs of conducting clinical trials,
including the ability or willingness of Exelixis’ clinical
collaboration partners to invest in the resources necessary to
complete the trials; Exelixis’ dependence on third-party vendors
for the development, manufacture and supply of zanzalintinib;
Exelixis’ ability to protect its intellectual property rights;
market competition; changes in economic and business conditions;
and other factors affecting Exelixis and its development programs
detailed from time to time under the caption “Risk Factors” in
Exelixis’ most recent Annual Report on Form 10-K and subsequent
Quarterly Reports on Form 10-Q, and in Exelixis’ future filings
with the Securities and Exchange Commission. All forward-looking
statements in this press release are based on information available
to Exelixis as of the date of this press release, and Exelixis
undertakes no obligation to update or revise any forward-looking
statements contained herein, except as required by law.
Arcus Forward-Looking Statements This press release
contains forward-looking statements. All statements regarding
events or results to occur in the future contained herein are
forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, the timing for enrollment of the
study, the potential of AB521 plus zanzalintinib and the enablement
of future development plans for AB521. All forward-looking
statements involve known and unknown risks and uncertainties and
other important factors that may cause Arcus’s actual results,
performance or achievements to differ significantly from those
expressed or implied by the forward-looking statements. Factors
that could cause or contribute to such differences include, but are
not limited to: difficulties or delays in initiating or conducting
clinical trials due to difficulties or delays in the regulatory
process, enrolling subjects or manufacturing or supplying product
for such clinical trials; the emergence of adverse events or other
undesirable side effects; the applicability of data resulting from
the study described herein to later trials; difficulties associated
with the management of the collaboration activities or expanded
clinical programs; changes in the competitive landscape for Arcus’s
programs; and the inherent uncertainty associated with
pharmaceutical product development and clinical trials. Risks and
uncertainties facing Arcus are described more fully in the “Risk
Factors” section of Arcus’s most recent Quarterly Report on Form
10Q filed with the U.S. Securities and Exchange Commission. You are
cautioned not to place undue reliance on the forward-looking
statements, which speak only as of the date of this press release.
Arcus disclaims any obligation or undertaking to update, supplement
or revise any forward-looking statements contained in this press
release except to the extent required by law.
Exelixis, the Exelixis logo and CABOMETYX are
registered U.S. trademarks of Exelixis.
__________________ 1 Key Statistics About
Kidney Cancer. American Cancer Society website. Available at:
https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html.
Accessed December 2023. 2 What Is Kidney Cancer? American Cancer
Society website. Available at
https://www.cancer.org/cancer/kidney-cancer/about/what-is-kidney-cancer.html.
Accessed December 2023. 3 Survival Rates for Kidney Cancer.
American Cancer Society website. Available at
https://www.cancer.org/cancer/kidney-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed December 2023. 4 Citeline’s Datamonitor Healthcare: Renal
Cell Carcinoma. September 2023 (internal data on file).
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Exelixis Investors Contact: Susan Hubbard EVP,
Public Affairs and Investor Relations Exelixis, Inc. (650) 837-8194
shubbard@exelixis.com
Exelixis Media Contact: Stekki Millman Senior
Director, Public Affairs Exelixis, Inc. (650) 837-7187
smillman@exelixis.com
Arcus Biosciences Investors Contact: Pia Eaves (Banerjee)
Head of Investor Relations & Strategy (617) 459-2006
peaves@arcusbio.com
Arcus Biosciences Media Contact: Holli Kolkey VP of
Corporate Communications (650) 922-1269 hkolkey@arcusbio.com
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